Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
3 Years
21 Years
Both
HIV, Cancer
Trial Information
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
The primary objectives of this study are to compare the immune response of Fluzone HD, a
high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children
with cancer and in children with HIV.
The secondary objectives of this study are to:
- Describe the safety and reactogenicity of high-dose and standard-dose TIV.
- Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and
standard-dose TIV.
- Describe the relationship between baseline lymphocyte numbers/function and
robustness/durability of the immune response.
Inclusion Criteria:
- Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached
their 22nd birthday) at the time of entry into the study.
- Written informed consent (and assent, if applicable) obtained.
- Participant has a diagnosis of cancer or HIV.
- If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the
treatment of cancer or has received chemotherapy in the past 12 weeks
Exclusion Criteria
- Severe hypersensitivity to egg proteins or any component of Fluzone, or
life-threatening reactions after any previous administration of any influenza
vaccine;
- History of Guillain-Barre´ syndrome in the subject or subject's family (parents,
siblings, half siblings, or children);
- Not willing to agree to acceptable birth control for three months after study
immunization
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of sero-conversion
Outcome Description:
Compare the immune responses of Fluzone HD to Fluzone in children with cancer or HIV. This is an open label, randomized study in two groups of patients.
Outcome Time Frame:
2 months after initial vaccine
Safety Issue:
No
Principal Investigator
Jonathan A McCullers, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Food and Drug Administration
Study ID:
FLUHD
NCT ID:
NCT01205581
Start Date:
September 2010
Completion Date:
August 2013
Related Keywords:
- HIV
- Cancer
- Fluzone
- Trivalent Influenza Vaccine
- Influenza, Human
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
